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A Study to Demonstrate Bioequivalence Between 6 x 2 mg Tablets of Perampanel and a Single 12 mg Tablet of Perampanel in Healthy Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01240187
First Posted: November 15, 2010
Last Update Posted: May 14, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eisai Inc.
  Purpose
The purpose of this study is to investigate the bioequivalence between 6 x 2 mg tablets and one 12 mg tablet of perampanel in healthy subjects.

Condition Intervention Phase
Partial Onset Epilepsy Drug: perampanel Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Crossover Study to Demonstrate Bioequivalence Between 6 x2 mg Tablets of Perampanel and a Single 12 mg Tablet of Perampanel in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • To evaluate and compare the pharmacokinetic (PK) profile, safety, and tolerability of 6 x 2-mg tablets of perampanel with a single 12-mg tablet. [ Time Frame: 12 weeks ]

Enrollment: 22
Study Start Date: June 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental 1 Drug: perampanel
Single dose of 6 tablets 2 mg orally
Experimental: Experimental 2 Drug: perampanel
Single dose of 1 tablet 12 mg orally

Detailed Description:
A Single Centre, open label, 2-period, 2-sequence crossover bioequivalence study in one group of 28 subjects.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male or female subjects aged between 18-55 years.
  • BMI of 18-32 kg/m ^2.
  • Willing and able to provide written informed consent.

Exclusion criteria:

  • Subjects taking prescribed or over the counter (OTC) medications in 2 weeks prior to screening.
  • Subjects on special diets or dietary aids known to modulate drug metabolizing enzymes.
  • Subjects who have taken inhibitor of CYP450 within 2 weeks of first dose.
  • Subjects who have received any experimental drug in the 12 weeks prior to study drug treatment.
  • Subjects with a history of alcohol abuse or who drink more than the recommended number of alcohol units per week.
  • Subjects who consume more than five caffeinated beverages per day.
  • Subjects who smoke more than 5 cigarettes per day.
  • Subjects with a history of drug abuse or who have a positive urine drug screening test.
  • Women who do not agree to use two methods of contraception.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01240187


Locations
United Kingdom
Quotient Clinical
Edinburgh, United Kingdom
Sponsors and Collaborators
Eisai Inc.
Investigators
Principal Investigator: Dr Joanne Collier Quotient Clinical
  More Information

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01240187     History of Changes
Other Study ID Numbers: E2007-E044-037
First Submitted: September 23, 2010
First Posted: November 15, 2010
Last Update Posted: May 14, 2013
Last Verified: May 2011

Keywords provided by Eisai Inc.:
epilepsy

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases